Trial Outcomes & Findings for A 24 Week Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema (NCT NCT05259722)
NCT ID: NCT05259722
Last Updated: 2025-05-09
Results Overview
The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers \[except fingertips\], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score) with a higher score indicating greater severity.
COMPLETED
PHASE3
513 participants
12 weeks
2025-05-09
Participant Flow
The trial enrolled adult participants with severe CHE and with a documented inadequate response to treatment with TCS or for whom TCS were documented to be otherwise medically inadvisable.
Randomization was stratified by subtype (hyperkeratotic/non-hyperkeratotic) and region (North America/Europe).
Participant milestones
| Measure |
Delgocitinib Cream 20 mg/g
Twice-daily topical application for up to 24 weeks.
Delgocitinib: Cream for topical application 20 mg/g.
There was a possibility to stop treatment after 16 weeks if IGA 0/1 was obtained.
|
Alitretinoin Capsules 30 mg Per Capsule
1 capsule per day for up to 24 weeks
Toctino: 1 capsule toctino 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur.
There was a possibility to stop treatment after 12 weeks if IGA 0/1 was obtained.
|
|---|---|---|
|
Overall Study
STARTED
|
254
|
259
|
|
Overall Study
COMPLETED
|
219
|
154
|
|
Overall Study
NOT COMPLETED
|
35
|
105
|
Reasons for withdrawal
| Measure |
Delgocitinib Cream 20 mg/g
Twice-daily topical application for up to 24 weeks.
Delgocitinib: Cream for topical application 20 mg/g.
There was a possibility to stop treatment after 16 weeks if IGA 0/1 was obtained.
|
Alitretinoin Capsules 30 mg Per Capsule
1 capsule per day for up to 24 weeks
Toctino: 1 capsule toctino 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur.
There was a possibility to stop treatment after 12 weeks if IGA 0/1 was obtained.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
24
|
|
Overall Study
Lost to Follow-up
|
5
|
1
|
|
Overall Study
Lack of Efficacy
|
8
|
26
|
|
Overall Study
Withdrawal by Subject
|
15
|
33
|
|
Overall Study
Various reasons
|
3
|
9
|
|
Overall Study
Not exposed to IMP
|
1
|
12
|
|
Overall Study
Discontinuation of IMP, related to COVID-19
|
1
|
0
|
Baseline Characteristics
A 24 Week Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema
Baseline characteristics by cohort
| Measure |
Delgocitinib Cream 20 mg/g
n=254 Participants
Twice-daily topical application for up to 24 weeks\>
\> Delgocitinib: Cream for topical application 20 mg/g
|
Alitretinoin Capsules 30 mg Per Capsule
n=259 Participants
1 capsule per day for up to 24 weeks\>
\> Toctino: 1 capsule toctino 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur
|
Total
n=513 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
238 Participants
n=5 Participants
|
233 Participants
n=7 Participants
|
471 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 13.78 • n=5 Participants
|
44.0 years
STANDARD_DEVIATION 14.56 • n=7 Participants
|
44.7 years
STANDARD_DEVIATION 14.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
167 Participants
n=5 Participants
|
167 Participants
n=7 Participants
|
334 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
226 Participants
n=5 Participants
|
241 Participants
n=7 Participants
|
467 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
237 Participants
n=5 Participants
|
240 Participants
n=7 Participants
|
477 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
25 participants
n=5 Participants
|
29 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
89 participants
n=5 Participants
|
91 participants
n=7 Participants
|
180 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
13 participants
n=5 Participants
|
9 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
France
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
63 participants
n=5 Participants
|
73 participants
n=7 Participants
|
136 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
36 participants
n=5 Participants
|
28 participants
n=7 Participants
|
64 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThe Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers \[except fingertips\], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score) with a higher score indicating greater severity.
Outcome measures
| Measure |
Delgocitinib Cream 20 mg/g
n=249 Participants
Twice-daily topical application for up to 24 weeks
Delgocitinib: Cream for topical application 20 mg/g
|
Alitretinoin Capsules 30 mg Per Capsule
n=250 Participants
1 capsule per day for up to 24 weeks
Toctino: 1 capsule toctino 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur
|
|---|---|---|
|
Change in HECSI Score From Baseline to Week 12
|
-67.6 score on a scale
Standard Error 3.37
|
-51.5 score on a scale
Standard Error 3.36
|
SECONDARY outcome
Timeframe: 12 weeksThe Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers \[except fingertips\], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity. HECSI-90 is defined as at least 90% improvement in HECSI score from baseline.
Outcome measures
| Measure |
Delgocitinib Cream 20 mg/g
n=249 Participants
Twice-daily topical application for up to 24 weeks
Delgocitinib: Cream for topical application 20 mg/g
|
Alitretinoin Capsules 30 mg Per Capsule
n=250 Participants
1 capsule per day for up to 24 weeks
Toctino: 1 capsule toctino 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur
|
|---|---|---|
|
HECSI-90 at Week 12
|
96 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: 12 weeksThe Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's global chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). IGA-CHE treatment success (IGA-CHE TS) is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from baseline.
Outcome measures
| Measure |
Delgocitinib Cream 20 mg/g
n=250 Participants
Twice-daily topical application for up to 24 weeks
Delgocitinib: Cream for topical application 20 mg/g
|
Alitretinoin Capsules 30 mg Per Capsule
n=253 Participants
1 capsule per day for up to 24 weeks
Toctino: 1 capsule toctino 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur
|
|---|---|---|
|
IGA-CHE TS at Week 12.
|
68 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: 12 weeksThe Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint will only assess the 'itch' component.
Outcome measures
| Measure |
Delgocitinib Cream 20 mg/g
n=238 Participants
Twice-daily topical application for up to 24 weeks
Delgocitinib: Cream for topical application 20 mg/g
|
Alitretinoin Capsules 30 mg Per Capsule
n=238 Participants
1 capsule per day for up to 24 weeks
Toctino: 1 capsule toctino 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur
|
|---|---|---|
|
Change in HESD Itch Score (Weekly Average) From Baseline to Week 12
|
-3.0 score on a scale
Standard Error 0.22
|
-2.4 score on a scale
Standard Error 0.21
|
SECONDARY outcome
Timeframe: 12 weeksThe Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint will only assess the 'pain' component.
Outcome measures
| Measure |
Delgocitinib Cream 20 mg/g
n=238 Participants
Twice-daily topical application for up to 24 weeks
Delgocitinib: Cream for topical application 20 mg/g
|
Alitretinoin Capsules 30 mg Per Capsule
n=238 Participants
1 capsule per day for up to 24 weeks
Toctino: 1 capsule toctino 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur
|
|---|---|---|
|
Change in HESD Pain Score (Weekly Average) From Baseline to Week 12.
|
-2.9 score on a scale
Standard Error 0.23
|
-2.3 score on a scale
Standard Error 0.23
|
SECONDARY outcome
Timeframe: 24 weeksThe Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers \[except fingertips\], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score) with a higher score indicating greater severity. HECSI-90 is defined as at least 90% improvement in HECSI score from baseline. The area under the curve (AUC) at participant level will be determined as follows: 1 will be assigned when response is observed and 0 otherwise. The AUC is interpreted as number of days with 90% reduction in HECSI score until Week 24.
Outcome measures
| Measure |
Delgocitinib Cream 20 mg/g
n=249 Participants
Twice-daily topical application for up to 24 weeks
Delgocitinib: Cream for topical application 20 mg/g
|
Alitretinoin Capsules 30 mg Per Capsule
n=250 Participants
1 capsule per day for up to 24 weeks
Toctino: 1 capsule toctino 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur
|
|---|---|---|
|
AUC of HECSI-90 From Baseline up to Week 24
|
51.1 days with 90% reduction in HECSI score
Standard Error 4.11
|
43.5 days with 90% reduction in HECSI score
Standard Error 4.22
|
SECONDARY outcome
Timeframe: 24 weeksThe Dermatology Life Quality Index (DLQI) is a validated questionnaire consisting of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their quality of life over the last week. The DLQI score is the sum of the 10 items (score ranging from 0 to 30); a high score is indicative of a poor quality of life. The area under the curve (AUC) at patient level will be determined from the change from baseline in DLQI score estimated as a piecewise linear function from Week 0 to Week 24. Differences will be analyzed with opposite sign to interpret positive area as improvement in scores and negative area as worsening.
Outcome measures
| Measure |
Delgocitinib Cream 20 mg/g
n=230 Participants
Twice-daily topical application for up to 24 weeks
Delgocitinib: Cream for topical application 20 mg/g
|
Alitretinoin Capsules 30 mg Per Capsule
n=236 Participants
1 capsule per day for up to 24 weeks
Toctino: 1 capsule toctino 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur
|
|---|---|---|
|
AUC of Change From Baseline in DLQI Score up to Week 24
|
1124.7 days * DLQI score reduction
Standard Error 61.37
|
790.7 days * DLQI score reduction
Standard Error 62.67
|
SECONDARY outcome
Timeframe: 24 weeksThe Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers \[except fingertips\], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score) with a higher score indicating greater severity.
Outcome measures
| Measure |
Delgocitinib Cream 20 mg/g
n=249 Participants
Twice-daily topical application for up to 24 weeks
Delgocitinib: Cream for topical application 20 mg/g
|
Alitretinoin Capsules 30 mg Per Capsule
n=250 Participants
1 capsule per day for up to 24 weeks
Toctino: 1 capsule toctino 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur
|
|---|---|---|
|
Change in HECSI Score From Baseline to Week 24
|
-69.6 score on a scale
Standard Error 3.78
|
-45.1 score on a scale
Standard Error 3.77
|
SECONDARY outcome
Timeframe: 26 weeksAn adverse event (AE) will be considered treatment emergent if started after the first application of investigational medicinal product (IMP), or if started before the first application of IMP and worsened in severity after first dose of IMP.
Outcome measures
| Measure |
Delgocitinib Cream 20 mg/g
n=253 Participants
Twice-daily topical application for up to 24 weeks
Delgocitinib: Cream for topical application 20 mg/g
|
Alitretinoin Capsules 30 mg Per Capsule
n=247 Participants
1 capsule per day for up to 24 weeks
Toctino: 1 capsule toctino 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur
|
|---|---|---|
|
Number of Treatment-emergent AEs From Baseline up to Week 26
|
280 events
|
620 events
|
SECONDARY outcome
Timeframe: 26 weeksA serious adverse event (SAE) will be considered treatment emergent if started after the first application of investigational medicinal product (IMP), or if started before the first application of IMP and worsened in severity after first dose of IMP.
Outcome measures
| Measure |
Delgocitinib Cream 20 mg/g
n=253 Participants
Twice-daily topical application for up to 24 weeks
Delgocitinib: Cream for topical application 20 mg/g
|
Alitretinoin Capsules 30 mg Per Capsule
n=247 Participants
1 capsule per day for up to 24 weeks
Toctino: 1 capsule toctino 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur
|
|---|---|---|
|
Number of Treatment-emergent SAEs From Baseline up to Week 26
|
5 events
|
12 events
|
SECONDARY outcome
Timeframe: 24 weeksThe investigational medicinal product (IMP) will be discontinued permanently in case of an AE that, in the opinion of the investigator or sponsor's medical expert, contraindicates further dosing. The investigator will assess the relationship between investigational medicinal product (IMP) and the adverse event (AE).
Outcome measures
| Measure |
Delgocitinib Cream 20 mg/g
n=253 Participants
Twice-daily topical application for up to 24 weeks
Delgocitinib: Cream for topical application 20 mg/g
|
Alitretinoin Capsules 30 mg Per Capsule
n=247 Participants
1 capsule per day for up to 24 weeks
Toctino: 1 capsule toctino 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur
|
|---|---|---|
|
Number of AEs Leading to IMP Discontinuation up to Week 24
|
4 events
|
44 events
|
Adverse Events
Delgocitinib Cream 20 mg/g
Alitretinoin Capsules 30 mg Per Capsule
Serious adverse events
| Measure |
Delgocitinib Cream 20 mg/g
n=253 participants at risk
Delgocitinib Cream 20 mg/g (N=253)
|
Alitretinoin Capsules 30 mg Per Capsule
n=247 participants at risk
Alitretinoin Capsules 30 mg Per Capsule (N=247)
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/253 • From baseline to Week 26
|
0.40%
1/247 • Number of events 1 • From baseline to Week 26
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.40%
1/253 • Number of events 1 • From baseline to Week 26
|
0.00%
0/247 • From baseline to Week 26
|
|
Injury, poisoning and procedural complications
Deep vein thrombosis postoperative
|
0.00%
0/253 • From baseline to Week 26
|
0.40%
1/247 • Number of events 1 • From baseline to Week 26
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/253 • From baseline to Week 26
|
0.40%
1/247 • Number of events 1 • From baseline to Week 26
|
|
Investigations
Blood potassium increased
|
0.40%
1/253 • Number of events 1 • From baseline to Week 26
|
0.00%
0/247 • From baseline to Week 26
|
|
Investigations
International normalised ratio increased
|
0.00%
0/253 • From baseline to Week 26
|
0.40%
1/247 • Number of events 1 • From baseline to Week 26
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/253 • From baseline to Week 26
|
0.40%
1/247 • Number of events 1 • From baseline to Week 26
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.40%
1/253 • Number of events 1 • From baseline to Week 26
|
0.00%
0/247 • From baseline to Week 26
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.40%
1/253 • Number of events 1 • From baseline to Week 26
|
0.00%
0/247 • From baseline to Week 26
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.40%
1/253 • Number of events 1 • From baseline to Week 26
|
0.40%
1/247 • Number of events 1 • From baseline to Week 26
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.00%
0/253 • From baseline to Week 26
|
0.40%
1/247 • Number of events 1 • From baseline to Week 26
|
|
Nervous system disorders
Headache
|
0.00%
0/253 • From baseline to Week 26
|
0.40%
1/247 • Number of events 1 • From baseline to Week 26
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/253 • From baseline to Week 26
|
0.40%
1/247 • Number of events 1 • From baseline to Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal cyst
|
0.00%
0/253 • From baseline to Week 26
|
0.40%
1/247 • Number of events 1 • From baseline to Week 26
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/253 • From baseline to Week 26
|
0.40%
1/247 • Number of events 1 • From baseline to Week 26
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/253 • From baseline to Week 26
|
0.40%
1/247 • Number of events 1 • From baseline to Week 26
|
Other adverse events
| Measure |
Delgocitinib Cream 20 mg/g
n=253 participants at risk
Delgocitinib Cream 20 mg/g (N=253)
|
Alitretinoin Capsules 30 mg Per Capsule
n=247 participants at risk
Alitretinoin Capsules 30 mg Per Capsule (N=247)
|
|---|---|---|
|
Eye disorders
Dry eye
|
0.00%
0/253 • From baseline to Week 26
|
2.8%
7/247 • Number of events 7 • From baseline to Week 26
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/253 • From baseline to Week 26
|
2.0%
5/247 • Number of events 5 • From baseline to Week 26
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/253 • From baseline to Week 26
|
3.2%
8/247 • Number of events 8 • From baseline to Week 26
|
|
Gastrointestinal disorders
Nausea
|
0.40%
1/253 • Number of events 1 • From baseline to Week 26
|
5.7%
14/247 • Number of events 15 • From baseline to Week 26
|
|
Infections and infestations
COVID-19
|
2.0%
5/253 • Number of events 5 • From baseline to Week 26
|
3.6%
9/247 • Number of events 9 • From baseline to Week 26
|
|
Infections and infestations
Nasopharyngitis
|
11.9%
30/253 • Number of events 38 • From baseline to Week 26
|
13.8%
34/247 • Number of events 46 • From baseline to Week 26
|
|
Infections and infestations
Upper respiratory tract infection
|
2.4%
6/253 • Number of events 8 • From baseline to Week 26
|
3.2%
8/247 • Number of events 8 • From baseline to Week 26
|
|
Infections and infestations
Urinary tract infection
|
0.40%
1/253 • Number of events 1 • From baseline to Week 26
|
4.0%
10/247 • Number of events 11 • From baseline to Week 26
|
|
Investigations
Blood triglycerides increased
|
0.79%
2/253 • Number of events 2 • From baseline to Week 26
|
2.8%
7/247 • Number of events 8 • From baseline to Week 26
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/253 • From baseline to Week 26
|
3.6%
9/247 • Number of events 10 • From baseline to Week 26
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.2%
3/253 • Number of events 3 • From baseline to Week 26
|
2.4%
6/247 • Number of events 7 • From baseline to Week 26
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.79%
2/253 • Number of events 2 • From baseline to Week 26
|
2.4%
6/247 • Number of events 6 • From baseline to Week 26
|
|
Nervous system disorders
Dizziness
|
0.40%
1/253 • Number of events 1 • From baseline to Week 26
|
2.4%
6/247 • Number of events 6 • From baseline to Week 26
|
|
Nervous system disorders
Headache
|
4.0%
10/253 • Number of events 19 • From baseline to Week 26
|
32.0%
79/247 • Number of events 113 • From baseline to Week 26
|
|
Nervous system disorders
Migraine
|
0.79%
2/253 • Number of events 2 • From baseline to Week 26
|
2.4%
6/247 • Number of events 7 • From baseline to Week 26
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.40%
1/253 • Number of events 1 • From baseline to Week 26
|
2.0%
5/247 • Number of events 6 • From baseline to Week 26
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.40%
1/253 • Number of events 1 • From baseline to Week 26
|
2.0%
5/247 • Number of events 5 • From baseline to Week 26
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.2%
3/253 • Number of events 3 • From baseline to Week 26
|
3.6%
9/247 • Number of events 9 • From baseline to Week 26
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.79%
2/253 • Number of events 2 • From baseline to Week 26
|
2.0%
5/247 • Number of events 6 • From baseline to Week 26
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.40%
1/253 • Number of events 1 • From baseline to Week 26
|
3.6%
9/247 • Number of events 10 • From baseline to Week 26
|
|
Vascular disorders
Flushing
|
0.00%
0/253 • From baseline to Week 26
|
2.0%
5/247 • Number of events 6 • From baseline to Week 26
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor seeks publication of all clinical trials in peer-reviewed journals within 12 months after completion or termination of the clinical trial, regardless of whether the findings are positive or negative. If no publication is submitted by the sponsor within these 12 months, the investigator has the right to publish the results from clinical trial generated by him/herself.
- Publication restrictions are in place
Restriction type: OTHER